510(k) clearances

InbellaBody System

Inbella Medical, Inc. · General, Plastic Surgery

K250200Substantially EquivalentSpecialGEI
Open FDA's page for this record
Third party flag
N
City
Richmond Hill
Advisory committee description
General, Plastic Surgery
Address 1
100 Leek Crescent, Unit 13
Statement or summary
Summary
Product code
GEI
Zip code
L4B 3E6
Applicant
Inbella Medical, Inc.
Decision date
2025-02-11
Decision code
SESE
Country code
CA
Device name
InbellaBody System
Advisory committee
SU
Contact
Michael Kreindel
K number
K250200
Date received
2025-01-23
Review advisory committee
SU
Postal code
L4B 3E6
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
1051614, 3029972466, 3007593903, 3015497424, 3013247477, 3021192541, 1062741, 1720747, 8010273, 2518897, 3007728276, 1057358, 3028977843, 3003537036, 1000523114, 3002806603, 2029015, 3007535734, 3004601121, 3009555600, 9681129, 3016248634, 3011944170, 3006266622, 3007047889, 3008864603, 3014931612, 3006985163, 3005110411, 3011625895, 3004837686, 8043746, 3004111573, 3002808148, 3033589330, 3043226252, 3043532708, 3022626486, 3008911114, 3010400367 +832 more
FEI number
1051614, 3029972466, 3007593903, 3015497424, 3013247477, 3021192541, 1720747, 1000136191, 3007728276, 3001319476, 3028977843, 3003537036, 1000523114, 3002806603, 3004601121, 3007535734, 3009555600, 1000208624, 3006469671, 3016248634, 3008185830, 3011944170, 2523865, 3006266622, 3007047889, 3008864603, 3014931612, 3006985163, 3005110411, 3011625895, 3002806575, 3004837686, 3004111573, 3002808148, 3033589330, 3043226252, 1000116158, 3043532708, 1000640985, 3022626486 +832 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.